- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01417208
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
July 29, 2022 updated by: 3M
The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP® (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wales
-
Cardiff, Wales, United Kingdom, CF14 4XN
- Section of Wound Healing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with diabetic foot ulceration, venous or mixed aetiology lower limb ulceration who are receiving out-patient treatment from the Section of Wound Healing, Cardiff University, Wales.
Description
Inclusion Criteria:
- Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease).
- Wound present for >30 days.
- Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings.
- Patient is able to comply with study protocol requirements.
- Patient is able to understand and provide written consent.
Exclusion Criteria:
- Patient has evidence of wound infection in the opinion of the physician.
- Patient has a thick eschar that persists after wound debridement.
- Patient has an HbA1C >12%.
- Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis.
- Patient has untreated osteomyelitis.
- Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study.
- Patient is allergic to the wound care device or occlusive dressing.
- Patient has exposed blood vessels.
- Patient is pregnant or pregnancy is suspected.
- Patient is actively participating in other clinical trials that may interfere with their participation in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
SNaP® Wound Care System
|
Wound dressing applications using customized system.
Dressing applications changes per manufacturer recommendation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound Closure
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
August 12, 2011
First Submitted That Met QC Criteria
August 15, 2011
First Posted (Estimate)
August 16, 2011
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 29, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 011711
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lower Extremity Diabetic Leg Wounds
-
Johns Hopkins UniversityUniversity of Maryland, Baltimore; McMaster University; Orthopaedic Trauma Association and other collaboratorsNot yet recruitingOpen Tibia Fracture | Extremity Fracture Lower | Open Dislocation of Ankle | Extremity Injuries Lower
-
Bahçeşehir UniversityRecruitingLower Extremity Problem | Balance Disorders | Foot InjuryTurkey
-
University of ÉvoraActive, not recruitingKnee Injuries | Rehabilitation | Lower Extremity ProblemPortugal
-
ColdplasmatechGerman Federal Ministry of Education and ResearchRecruitingChronic Ulcer of Lower ExtremityGermany
-
Texas Health ResourcesCelleration, Inc.CompletedChronic Ulcer of Lower ExtremityUnited States
-
University of MichiganCommunity Foundation of Greater FlintActive, not recruitingAnterior Cruciate Ligament Injuries | Lower Extremity ProblemUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedAnterior Cruciate Ligament Injuries | Knee Injuries | Ankle Injuries | Lower Extremity InjuriesUnited States
-
Loma Linda UniversityNitric BioTherapeutics, IncTerminatedChronic Ulcer of Lower ExtremityUnited States
-
MediWound LtdCompletedVenous Leg Ulcers | Hard to Heal Wounds | Diabetic Lower Extremity Ulcers | Traumatic/ Post Operative WoundsIsrael
-
Inari MedicalActive, not recruitingDVT | Deep Vein Thrombosis Leg | Chronic DVT of Lower Extremity | Acute DVT of Lower ExtremityUnited States
Clinical Trials on SNaP® Wound Care System
-
3MWithdrawnSkin Graft | Split Thickness Skin Graft | Skin Cancer Excision SiteUnited States
-
3MCompletedSurgical Wound, Recent | Trauma-related WoundUnited States
-
3MWithdrawnDiabetic Foot Ulcers | Venous Stasis Ulcers | Pressure Ulcers | Trauma Wounds | Acute and Chronic WoundsUnited States
-
Stanford University3MCompleted
-
3MCompletedWounds | UlcersUnited States
-
RedDress Ltd.CompletedNeuropathic Diabetic Ulcer - FootUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingObesity | Malignant Breast Neoplasm | Body Mass Index Greater Than or Equal to 30 | Mammoplasty PatientUnited States
-
Kansas State UniversityThe Sunflower FoundationCompleted
-
Ottawa Hospital Research InstituteCompleted